Codon

JUNE 18, 2024

For more than a century, scientists thought of gas vesicles as little more than a natural curiosity and, later, as a way for microbes to regulate buoyancy. Right) The passage of text from a 2010 review that inspired Mikhail Shapiro to engineer gas vesicles. Voigt, Biotechnology Journal (2010). 31,500x magnification.

Engineering 70

Engineering Laboratories International Clinical Trials 70

Agency IQ

JUNE 2, 2023

The FDA recently concluded its work on a proposed rule focused on PMI. The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The content of the PMI : The regulation describes, in broad terms, what must be included in the PMI.

FDA 40

FDA FDA Approval Production Regulations 40

The Pharma Data

AUGUST 3, 2021

Food and Drug Administration (FDA) approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. In May, the U.S. Bemarituzumab. Tarlatamab (AMG 757). AMG 451 / KHK4083.

Biosimilars 52

Biosimilars Production Treatment FDA 52

Agency IQ

OCTOBER 20, 2023

Biosimilars are biological products that are highly similar (but not identical) to a previously approved biological product and have “no clinically meaningful” differences relative to the original reference product. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

Codon

MARCH 24, 2024

This was the founding ethos of Moderna, the mRNA vaccine developer, when it was launched in 2010 by Noubar Afeyan and Doug Cole at Flagship Pioneering. In response to this hysteria, regulation was aggressively tightened. An alternative approach is to make molecules not in tubes, vials, or cells, but inside the body itself.

Engineering 87

Engineering Vaccine Production RNA 87

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. 2010; 116(20): 4777–4787. BTK signaling is needed by specific cancer cells to multiply and spread. Accessed May 2021. 3 Shanafelt, et al.

Treatment 52

Treatment Therapies FDA FDA Approval 52

The Pharma Data

JUNE 18, 2021

IMBRUVICA is the only FDA-approved medicine in WM and cGVHD. IMBRUVICA was one of the first medicines to receive FDA approval via the Breakthrough Therapy Designation pathway. 2010; 116(20): 4777–4787. BTK signaling is needed by specific cancer cells to multiply and spread. Accessed May 2021. 4 Shanafelt, et al.

Treatment 40

Treatment FDA Therapies FDA Approval 40

Drug & Device Law

FEBRUARY 15, 2024

As the DDL blog has previously reported , Michigan’s longstanding presumption of non-defectiveness applicable to FDA-approved drugs was recently repealed by the Michigan legislature in S.B. As this provision is newly applicable to FDA-approved products, it has not been tested by the courts on this issue. See Prasol v.

Production 52

Production FDA Approval FDA Compliance 52

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. 23, 2010) ( here ), can supersede our list, so far they’ve been thankfully uncommon. Holley also allowed a “pre-approval” warning claim to escape preemption, largely on the same rationale.

FDA Approval 52

FDA Approval FDA Drugs Production 52

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.” at 237-38.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

DECEMBER 30, 2022

When you hear Class III medical device product liability case, you should look for all claims to be dismissed unless there is something as unusual as a basis to claiming the plaintiff’s particular device deviated from its FDA-approved specifications. An unfortunate fiction developed post- Buckman —particularly after Riegel v.

FDA 59

FDA Regulations FDA Approval Production 59

Drug & Device Law

MARCH 25, 2022

Even before the anti-osteoporosis drug Fosamax was FDA approved, its manufacturer was aware of a biologically plausible mechanism for that class of drug (“bisphosphonates”) to cause low-energy – later renamed “atypical” ? At the FDA’s suggestion, the manufacturer withdrew that supplement, but kept trying. femur fractures.

FDA 52

FDA Regulations Science Drugs 52